CytoSorbents spikes on FDA submission for DrugSorb-ATR [Seeking Alpha]
Cytosorbents Corporation (CTSO)
Last cytosorbents corporation earnings: 11/5 04:15 pm
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Source: Seeking Alpha
Cytosorbents ( CTSO ) seeks regulatory clearance for DrugSorb-ATR to contain perioperative bleeding in patients on AstraZeneca's ( AZN ) blood thinner ticagrelor (Brilinta) who are undergoing coronary artery bypass surgery. The Princeton, New Jersey-based medical device maker said that the De Novo marketing application submitted on September 27, 2024, is expected to receive FDA priority review as the agency has granted breakthrough device designation for DrugSorb-ATR. Concurrently, Cytosorbents ( CTSO ) announced its Medical Device License (MDL) application for DrugSorb-ATR is ready for submission in Canada pending the Medical Device Single Audit Program (MDSAP) certification, which it expects to receive in the near term. More on Cytosorbents Cytosorbents Corporation (CTSO) Q2 2024 Earnings Call Transcript Seeking Alpha's Quant Rating on Cytosorbents Historical earnings data for Cytosorbents Financial information for Cytosorbents Recommended For You Comments M
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News
- CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP CertificationGlobeNewswire
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive ReviewGlobeNewswire
- CytoSorbents to Report Third Quarter 2024 Operating and Financial ResultsGlobeNewswire
CTSO
Earnings
- 8/13/24 - Beat
CTSO
Analyst Actions
- 8/14/24 - HC Wainwright
CTSO
Sec Filings
- 10/8/24 - Form 4
- 10/8/24 - Form 4
- 10/1/24 - Form 8-K
- CTSO's page on the SEC website